510(k) · Cleared
Recalled · Class I · 2022Trilogy 100 Ventilator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics Inc., Sleep & Home Respiratory Group · CBK Ventilator, Continuous, Facility Use
Cleared on Mar 13, 2009 as substantially equivalent to K070328 (Respironics Inc., Sleep & Home Respiratory Group, 2007) and 4 other predicates after a 105-day review. Its family tree reaches back 5 generations to 1991. 13 of the 58 devices in its family, counting itself, have a Class I recall. 26 later devices descend from it. It has been recalled 8 times, including 5 Class I recalls.
- Decided
- Mar 13, 2009
- Review
- 105 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 8 (5 Class I)
- Predicates
- 5
Its longest line of descent runs back 5 generations to K902859 (1991). 31 ancestors in all, the oldest K841279 (1984). 26 later devices descend from it, 6 citing it directly. 13 of the 58 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 4 generations backK961687 EVITA 4Drager, Inc. · 1996
- 3 generations backK970165 Evita 2 DuraDrager, Inc. · 1997
- 2 generations backK041775 GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2004
- 1 generation backK051767 LTV 1000 VentilatorPulmonetic Systems, Inc. · 2005
- This deviceK083526 Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009
- Descendant · cites it directly · 19 of its ownK093416 Trilogy 200 VentilatorRespironics, Inc. · 2010 · Recalled (Class I)
- Descendant · cites it directly · 11 of its ownK111610 Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · Recalled (Class I)
- Descendant · 2 generations on · 10 of its ownK133868 Astral VentilatorResmed, Ltd. · 2014 · Recalled
- Descendant · cites it directly · 9 of its ownK112754 IVENT101Versamed Medical Systems, Ltd. · 2012
- Descendant · 2 generations on · 8 of its ownK123144 VIVO 50Ge Healthcare, Breas Medical AB · 2013 · Recalled
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 26 · See all- K093416Trilogy 200 VentilatorRespironics, Inc. · 2010 · cites it directly19descendants
- K111610Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · cites it directly11descendants
- K133868Astral VentilatorResmed, Ltd. · 2014 · 2 generations on10descendants
- K112754IVENT101Versamed Medical Systems, Ltd. · 2012 · cites it directly9descendants
- K123144VIVO 50Ge Healthcare, Breas Medical AB · 2013 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −4 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| −3 | K970165 | Evita 2 Dura | Drager, Inc. | 1997 | — |
| −2 | K041775 | GE Datex-Ohmeda Engstrom Carestation | Datex-Ohmeda, Inc. | 2004 | — |
| −1 | K051767 | LTV 1000 Ventilator | Pulmonetic Systems, Inc. | 2005 | — |
| 0 (this device) | K083526 | Trilogy 100 Ventilator | Respironics Inc., Sleep & Home Respiratory Group | 2009 | — |
| +1 | K093416 | Trilogy 200 Ventilator | Respironics, Inc. | 2010 | Class I |
| +1 | K111610 | Trilogy Series Ventilator with Oximetry | Respironics, Inc. | 2011 | Class I |
| +2 | K133868 | Astral Ventilator | Resmed, Ltd. | 2014 | 2 |
| +1 | K112754 | IVENT101 | Versamed Medical Systems, Ltd. | 2012 | — |
| +2 | K123144 | VIVO 50 | Ge Healthcare, Breas Medical AB | 2013 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 2 | 0 |
| 1990 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 1 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 1 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 1 |
| 2011 | 1 | 1 |
| 2012 | 5 | 1 |
| 2013 | 2 | 1 |
| 2014 | 2 | 0 |
| 2016 | 4 | 1 |
| 2017 | 1 | 1 |
| 2018 | 1 | 1 |
| 2019 | 3 | 2 |
| 2021 | 1 | 1 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
13 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CBK device
- #1 K252663 Inbentus Versatilescore 16.0 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K070328 | Bipap Synchrony with AvapsSummary page 1…supporting Proprietary Name Respironics Trilogy 100 Ventilator Ventilatory Support System Predicate Device(s) Respironics BiPAP Synchrony with AVAPS (K070328) Respironics PLV Continuum P2000 (K022750) Pulmonetic LTV-1000 (K984056/K… | 2007 |
| * | K022750 | PLV Continuum Ventilator, Model P1000Summary page 1…ator Ventilatory Support System Predicate Device(s) Respironics BiPAP Synchrony with AVAPS (K070328) Respironics PLV Continuum P2000 (K022750) Pulmonetic LTV-1000 (K984056/K051767) Newport Medical HT-50 (K9912133)… | 2003 |
| * | K984056 | LTV 1000Summary page 1…Respironics BiPAP Synchrony with AVAPS (K070328) Respironics PLV Continuum P2000 (K022750) Pulmonetic LTV-1000 (K984056/K051767) Newport Medical HT-50 (K9912133) Reason for submission New Device… | 1999 |
| * | K051767 | LTV 1000 VentilatorSummary page 1…onics BiPAP Synchrony with AVAPS (K070328) Respironics PLV Continuum P2000 (K022750) Pulmonetic LTV-1000 (K984056/K051767) Newport Medical HT-50 (K9912133) Reason for submission New Device… | 2005 |
| * | K992133 | Newport HT50 Ventilator with Humidifier HT50-H, Newport HT50 Ventilator Without…Summary page 5…Modes of Operation (Positive Pressure Ventilation, Assist/Control, SIMV, CPAP) The following features are either unchanged or similar to the Newport Medical HT-50 (K992133): 000021 Ab… | 2000 |
What descends from it? (26)
See all 266 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (13 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 7, 2022 | Class I | Z-0884-2023 | Process design | The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which… |
| Dec 7, 2022 | Class I | Z-0882-2023 | Process design | The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which… |
| Jun 14, 2021 | Class I | Z-1956-2021 | Device Design | The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals. |
| Jan 18, 2016 | Class II | Z-1065-2016 | Software design | Software Issue |
| Feb 11, 2014 | Class I | Z-1143-2014 | Component design/selection | Internal testing revealed a potentially defective component on the power management board that could affect the function of certain Trilogy Ventilators resulting in loss of therapy to patients. |
| Apr 27, 2012 | Class I | Z-2024-2012 | Component design/selection | The specified Trilogy units are being recalled because of the potential for a faulty component in the power supply. |
| Oct 11, 2011 | Not classified | Z-0296-2012 | Process design | Trilogy 100, 200 and 202 units are being recalled due to low impeller press-force used during the manufacturing process. If the press force were low enough, theoretically the impeller could move up the shaft and come into contact with the… |
| Jun 10, 2010 | Not classified | Z-1896-2010 | Nonconforming Material/Component | It is possible that the battery could electrically short, resulting in a potential for fire or a thermal event. |
The 5 latest of 8 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 2 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 3 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K093416Trilogy 200 VentilatorRespironics, Inc. · 2010 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 14 Class I recalls
- K111610Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
- K181170Trilogy Evo UniversalRespironics, Inc. · 2019 · 2 generations on · ◆ in the 2019 descendants bar of FIG. 112 Class I recalls
- K181166Trilogy EvoRespironics, Inc. · 2019 · 2 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K122715Stellar 150Resmed Germany, Inc. · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 114 Class I recalls
- K152068Astral 100/150Resmed, Ltd. · 2016 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K193586Vivo 45 LSBreas Medical AB · 2021 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K172875Astral 100/150Resmed, Ltd. · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 12 Class I recalls
Nearest 5 of 12; all are on the web page.
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- 14 of the 31 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K093416 (Respironics, Inc., 2010) has gone furthest, with 19 descendants of its own.
- 3 other devices also cite its predicate K070328.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · CBK
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CBK
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBK
14in 2024
Class I (81 since 2007) Class II/III not classified
Adverse event reports per year · CBK
13,991in 2025
MAUDE reports naming product code CBK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 11 | 142 | 17 | 1,531 |
| 2008 | 18 | 115 | 23 | 1,933 |
| 2009 | 12 | 122 | 8 | 1,766 |
| 2010 | 14 | 150 | 9 | 1,799 |
| 2011 | 13 | 192 | 12 | 1,877 |
| 2012 | 17 | 207 | 2 (1) | 5,509 |
| 2013 | 5 | 277 | 5 (2) | 7,921 |
| 2014 | 5 | 439 | 5 (4) | 7,600 |
| 2015 | 7 | 266 | 6 (4) | 11,876 |
| 2016 | 4 | 323 | 4 (1) | 16,056 |
| 2017 | 6 | 280 | 1 | 14,451 |
| 2018 | 4 | 183 | 3 (3) | 9,849 |
| 2019 | 8 | 435 | 14 (13) | 9,100 |
| 2020 | 5 | 176 | 4 | 11,096 |
| 2021 | 6 | 267 | 21 (19) | 13,322 |
| 2022 | 0 | — | 8 (4) | 15,974 |
| 2023 | 5 | 309 | 4 (3) | 24,928 |
| 2024 | 9 | 203 | 14 (14) | 20,336 |
| 2025 | 4 | 163 | 0 | 13,991 |
| 2026 | 3 | 235 | 15 (13) | — |
What is it indicated for?
The Respironics Trilogy100 system provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Trilogy100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.).
The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083526 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083526: Trilogy 100 Ventilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083526
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026